# Persistent Post-Mastectomy Pain: Randomized Clinical Trial of Targeted Pain Coping Skills Training (Targeted-PCST) with Mediational Analysis

> **NIH NIH R01** · DUKE UNIVERSITY · 2021 · $630,676

## Abstract

Abstract
Persistent pain following breast cancer surgery is increasingly recognized as an important clinical and public
health issue due to the large number of women affected, the powerful negative impact that persistent pain has
on emotional and physical functioning and its financial costs. Most of the more than a quarter of a million
women newly diagnosed with breast cancer in the U.S. this year will undergo surgery as a part of curative
treatment. The prevalence of persistent pain following surgical removal of the affected breast (mastectomy) or
more limited surgeries (lumpectomy) is high, ranging from 25-60% across studies. Unlike acute post-operative
pain, which is a normal response to surgical trauma, persistent pain at or near the surgical site has an
uncertain multifaceted etiology, and no satisfactory pharmacological treatment. A critical question is whether
key pain-related psychosocial factors are drivers of the continuing burden of persistent pain, and whether they
could be ameliorated by non-pharmacological intervention. The research planned under this award will provide
a first critical test of the hypothesized driving role of pain catastrophizing in persistent pain after breast cancer
surgery. It also will explore the role of two other key psychosocial variables that may contribute to the burden
associated with persistent pain after breast cancer surgery: self-efficacy for engaging in valued activities and
psychological inflexibility. We have developed, manualized, and pilot tested a pain coping skills training
intervention that specifically targets the needs of women with persistent pain following breast cancer surgery
(Targeted PCST) and aims to reduce pain catastrophizing, increase self-efficacy for engaging in valued
activities, and decrease psychological inflexibility. We propose a multiple-site, randomized clinical trial to
evaluate the efficacy of the Targeted-PCST intervention. The study will be conducted in 9 diverse oncology
clinics: 5 affiliated with Duke University/Duke Cancer Network and 4 affiliated with the University of
Pittsburgh/UPMC Hillman Cancer Center. Participants (N=564) will be randomized to either receive: 1)
Targeted-PCST, 2) a general health education intervention (control), or 3) usual care (control). Participants will
complete assessments pre-intervention and at 3 months (post-intervention), 6 months follow-up, and 12
months follow-up. Study aims are: Aim1: Examine the impact of Targeted-PCST on persistent post-surgical
pain severity and interference (i.e., PEG score), emotional distress (anxiety and depression), and cancer-
specific distress. Aim 2: Investigate the impact of Targeted-PCST on pain catastrophizing, pain self-efficacy,
and psychological inflexibility, and evaluate these variables as possible mediators of the benefits of Targeted-
PCST. Aim 3: Evaluate the impact of Targeted-PCST on pain sensitivity and central sensitization, and explore
whether changes in these variables mediate group di...

## Key facts

- **NIH application ID:** 10132273
- **Project number:** 5R01CA249959-02
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** DANA H. BOVBJERG
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $630,676
- **Award type:** 5
- **Project period:** 2020-04-01 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10132273

## Citation

> US National Institutes of Health, RePORTER application 10132273, Persistent Post-Mastectomy Pain: Randomized Clinical Trial of Targeted Pain Coping Skills Training (Targeted-PCST) with Mediational Analysis (5R01CA249959-02). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10132273. Licensed CC0.

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